The Effects of an Interdisciplinary Treatment Approach in ESRD Patients: a Randomised Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- muscle mass
Study Overview
Brief Summary
This study is a randomised controlled intervention trial for patients with chronic kidney disease who are on the waiting list for a kidney transplantation (n=200). The aim of this study is to test the effectiveness of intensive individual nutritional and exercise support combined with comprehensive rehabilitation before transplantation in comparison to a control group.
Detailed Description
Patients are randomised to either the intervention or control group at the beginning of the study. Both groups are evaluated at the beginning after 6 months and after 12 months regarding their body composition, physical performance, blood values, quality of life and nutritional status. The control group only receives support via app during the study period (1 year), through which they receive detailed information about dialysis. In addition to access to the app, the intervention group receives individual recommendations for nutrition and exercise as well as a three-week inpatient rehabilitation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients must be on dialysis
- •Patients ≥ 18 years of age
- •Patients who own a smartphone
- •Patients must be willing to undergo inpatient rehabilitation within the project period
- •signed informed consent and data protection regulation
Exclusion Criteria
- •Patients who are not psychologically or physically able to take part in exercise promotion measures and/or nutritional counselling as well as psychological offers
- •Patients who have already participated in a similar project
Outcomes
Primary Outcomes
muscle mass
Time Frame: 6 and 12 month
measured in kg by bio-impedance analysis
body fat mass
Time Frame: 6 and 12 month
measured in kg by bio-impedance analysis
Secondary Outcomes
- Timed-up-and-go test (TUG)(6 and 12 month)
- One-Legged Stance Test(6 and 12 month)
- Stair Climb Test(6 and 12 month)
- Quality of life by Short Form Health Survey (SF-12)(6 and 12 month)
- Sit-to-stand test (STS60)(6 and 12 month)
- Fried Frailty Scale(6 and 12 month)
- Six-Minutes-Walk test (6MWT)(6 and 12 month)